Dry EyesVCOCLNCT06071780
Virgin Coconut Oil Contact Lens as Ocular Rewetting Agent
A study testing organic product - Virgin Coconut Oil in people with Dry Eyes, run by National University of Malaysia at 1 site in Malaysia.
Trial summary
This is a clinical trial where 44 subjects dry eyes were instilled with Virgin Coconut Oil (VCO CL) using contact lenses as its vehicle. All subjects are healthy subjects with no other ocular diseases except for having some dry eye symptoms (included with McMonnies questionnaires). Read more about this study
- Who is it for?
- Ages 19 to 28 yearsHealthy volunteers can take part
- Conditions the study is for
- Dry Eyes
- What is being tested?
- organic product - Virgin Coconut Oil
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 44 participants
- Where
- 1 siteMalaysia
- Study dates
- 15 Jan 2019to 14 Mar 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 28 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Dry eye symptoms (according to McMonnies questionaires)
- Written consent
Who cannot join
- No ocular diseases
- No systemic diseases
- Not wearing contact lenses regularly for the past 6 months
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Efficacy of Virgin Coconut Oil Contact Lens as Ocular Rewetting Agent on Dry Eyes
This is a clinical trial where 44 subjects dry eyes were instilled with Virgin Coconut Oil (VCO CL) using contact lenses as its vehicle. All subjects are healthy subjects with no other ocular diseases except for having some dry eye symptoms (included with McMonnies questionnaires). Parameters measured at baseline and after 15 minutes of insertion and were compared. The control eyes were inserted with contact lenses soaked in saline (CCL). The eye that wears the VCO CL or the CCL were chosen randomly by masked operator. At the end of this study, the parameters measured will indicate if the VCO CL was able to retain tears in the eye and remove the dry eyes symptoms.
Read the detailed description
A new study using contact lens pre-soaked in virgin coconut oil (VCO CL) was conducted to determine the safety of the agent on dry eye human. Efficacy of the VCO CL was assessed by measuring TBUT, anterior eye assessment, corneal staining, pH, and Schirmer value and the measurement of residual VCO volume in tears before instillation (0 minute) and at 15 minutes after insertion. Wilcoxon Signed Rank and Mann Whitney U Test were used to analyse any changes in all the measurable variables. The differences of the TBUT, corneal staining and residual VCO volume in tears value in both eyes were analyzed. These study data will suggest if the VCO CL is safe and effective and can be recommended to be used as an option for dry eyes in human
- Conditions
- Dry Eyes
- Being tested
- organic product - Virgin Coconut Oil
- Keywords
- Contact lens, VCO, TBUT, dry eyes
- Medical subject headings
- Dry Eye Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
organic product - Virgin Coconut OilOther
A commercially available sterilized contact lens was soaked in VCO for 4 hours in a sterile condition to allow absorption of VCO into the contact lens polymer. The contact lens here is a vehicle to transport the VCO into the eye.
| Study group | Role | What they receive |
|---|---|---|
| VCO contact lens | Active comparator | contact lens soaked in VCO Receives: Other: organic product - Virgin Coconut Oil |
| control contact lens | Placebo comparator | contact lens soaked in saline Receives: Other: organic product - Virgin Coconut Oil |
What is being measured
The primary outcome is the main question the study is designed to answer.
To compare the value of Tear Break-Up Time (TBUT) at baseline and 15 minutes after intervention
This is to evaluate the 'oil' component in the tearfilm
Measured: 15 minutes
To compare the value of Schimer's Test at baseline and 15 minutes after intervention
This is to evaluate the aqueous component in the tear film
Measured: 15 minutes
To compare the value of Corneal staining at baseline and 15 minutes after intervention
Fluorescein staining will indicate dry spots
Measured: 15 minutes
To measure the oil stained area after intervention and to compare it with the control group
This oil stain will indicate the residual of VCO left in the eye after 15 minutes.
Measured: 15 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2023
- Study start15 Jan 2019
- Primary completion14 Dec 2021
- Study completion14 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Dry EyesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Both eyes of subjects will be instilled with either one of the study contact lens or the control lens at random.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- National University of Malaysia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Assoc Prof Dr Haliza Abdul Mutalib, National University of Malaysia
- Investigators
- Haliza Abdul Mutalib, MOptom, Principal investigator, National University of Malaysia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06071780
- Sponsor's protocol ID
- UKM1.21.3/244/NN-2019-042
- Acronym
- VCOCL
- Status last verified
- Oct 2023
- First submitted
- 16 Sep 2023
- Last updated
- 6 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: when requested will be considered
Publications
Mutalib HA, Kaur S, Ghazali AR, Chinn Hooi N, Safie NH. A pilot study: the efficacy of virgin coconut oil as ocular rewetting agent on rabbit eyes. Evid Based Complement Alternat Med. 2015;2015:135987. doi: 10.1155/2015/135987. Epub 2015 Feb 23.
PubMed 25802534
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy of Virgin Coconut Oil Contact Lens as Ocular Rewetting Agent on Dry Eyes
- ClinicalTrials.gov ID
- NCT06071780
- Acronym / sponsor ID
- VCOCL / UKM1.21.3/244/NN-2019-042
- Conditions
- Dry Eyes
- Keywords
- Contact lens, VCO, TBUT, dry eyes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- National University of MalaysiaUniversity, hospital or other
- Study start
- 15 Jan 2019 (actual)
- Primary completion
- 14 Dec 2021 (actual)
- Study completion
- 14 Mar 2023 (actual)
- First posted
- 6 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a clinical trial where 44 subjects dry eyes were instilled with Virgin Coconut Oil (VCO CL) using contact lenses as its vehicle. All subjects are healthy subjects with no other ocular diseases except for having some dry eye symptoms (included with McMonnies questionnaires). Parameters measured at baseline and after 15 minutes of insertion and were compared. The control eyes were inserted with contact lenses soaked in saline (CCL). The eye that wears the VCO CL or the CCL were chosen randomly by masked operator. At the end of this study, the parameters measured will indicate if the VCO CL was able to retain tears in the eye and remove the dry eyes symptoms.
Detailed description
A new study using contact lens pre-soaked in virgin coconut oil (VCO CL) was conducted to determine the safety of the agent on dry eye human. Efficacy of the VCO CL was assessed by measuring TBUT, anterior eye assessment, corneal staining, pH, and Schirmer value and the measurement of residual VCO volume in tears before instillation (0 minute) and at 15 minutes after insertion. Wilcoxon Signed Rank and Mann Whitney U Test were used to analyse any changes in all the measurable variables. The differences of the TBUT, corneal staining and residual VCO volume in tears value in both eyes were analyzed. These study data will suggest if the VCO CL is safe and effective and can be recommended to be used as an option for dry eyes in human
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Both eyes of subjects will be instilled with either one of the study contact lens or the control lens at random.
| Arm | Type | Receives |
|---|---|---|
| VCO contact lens | Active comparator | Other: organic product - Virgin Coconut Oilcontact lens soaked in VCO |
| control contact lens | Placebo comparator | Other: organic product - Virgin Coconut Oilcontact lens soaked in saline |
Who may qualify
- Ages
- 19 to 28 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Dry eye symptoms (according to McMonnies questionaires)
- Written consent
Key exclusion criteria (3 listed)
- No ocular diseases
- No systemic diseases
- Not wearing contact lenses regularly for the past 6 months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| organic product - Virgin Coconut OilA commercially available sterilized contact lens was soaked in VCO for 4 hours in a sterile condition to allow absorption of VCO into the contact lens polymer. The contact lens here is a vehicle to transport the VCO into the eye. | Other | VCO contact lens, control contact lens |
Primary outcome
To compare the value of Tear Break-Up Time (TBUT) at baseline and 15 minutes after intervention
Time frame: 15 minutes
This is to evaluate the 'oil' component in the tearfilm
To compare the value of Schimer's Test at baseline and 15 minutes after intervention
Time frame: 15 minutes
This is to evaluate the aqueous component in the tear film
To compare the value of Corneal staining at baseline and 15 minutes after intervention
Time frame: 15 minutes
Fluorescein staining will indicate dry spots
To measure the oil stained area after intervention and to compare it with the control group
Time frame: 15 minutes
This oil stain will indicate the residual of VCO left in the eye after 15 minutes.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2023.
- Results publication: PubMed 25802534Mutalib HA, Kaur S, Ghazali AR, Chinn Hooi N, Safie NH. A pilot study: the efficacy of virgin coconut oil as ocular rewetting agent on rabbit eyes. Evid Based Complement Alternat Med. 2015;2015:135987. doi: 10.1155/2015/135987. Epub 2015 Feb 23.
- Individual participant dataSharing planned: Undecided. when requested will be considered
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Haliza Abdul Mutalib, MOptom principal investigator
National University of Malaysia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing organic product - Virgin Coconut Oil in people with Dry Eyes, run by National University of Malaysia at 1 site in Malaysia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Malaysia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To compare the value of Tear Break-Up Time (TBUT) at baseline and 15 minutes after intervention (time frame: 15 minutes). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06071780, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Oct 2023.